Good Day BIO: Gene editing allows pig-heart transplant

In an incredible step forward for medicine, gene editing (and a few BIO members) allowed doctors to successfully transplant a pig's heart into a human. We have the story. Plus, four federal health officials appeared before the Senate HELP Committee yesterday, so we tell you the useful information you might have missed if you only caught the buzzy clips. (656 words, 3 minutes, 16 seconds)

Gene editing allows pig-heart transplant

The first successful transplant of a pig’s heart into a human, performed Friday, relied on gene editing to make the pig’s organ more compatible with human anatomy—a revolution that could help resolve the shortage of organs for human transplant.

Here's the story: The eight-hour operation on David Bennett Sr. took place at University of Maryland Medical Center and was announced Monday, after the new organ was functioning well. Bennett was too ill to receive a human transplant, so doctors applied for this experimental procedure and the FDA gave emergency authorization on New Year’s Eve, The New York Times reports.

The so-called “Xenoheart” came from a pig that received 10 gene edits by scientists at Revivicor, a subsidiary of United Therapeutics (both BIO members).

Four of the pig’s genes were inactivated, including one that would have made the heart keep growing and another that causes human rejection, the Times explained. Another six human genes were inserted into the pig’s genome, to help Bennett’s immune system tolerate the organ. 

The human immune response to the heart was suppressed, using an experimental drug produced by BIO member Kiniksa Pharmaceuticals. 

What they’re saying: “This was a breakthrough surgery and brings us one step closer to solving the organ shortage crisis. There are simply not enough donor human hearts available to meet the long list of potential recipients,” said Dr. Bartley P. Griffith, who surgically transplanted the pig heart into the patient. 

Why it matters: Gene edited pigs are an excellent source of “xeno organs,” organs from other species for human use, said University of Maryland Medical School. The operation “is another step in the investigation of xeno organs for human use,” said David Ayares, PhD, CSO of Revivicor, Inc.



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Grilled on pandemic response, federal officials promote vaccination

Federal health officials stressed the importance of COVID-19 vaccines and testing—and faced tough questions from both Republicans and Democrats on changing guidance and availability of tests during yesterday’s four-hour-plus Senate Health, Education, Labor, and Pensions (HELP) Committee hearing. Here's what you might have missed if you only saw the buzzy clips.

Guidance in response to Omicron was a bipartisan theme. Chair Patty Murray (D-WA) said constituents have been frustrated by changing CDC guidelines and insufficient COVID tests, while Ranking Member Richard Burr (R-NC) urged the administration to “restore confidence” with improved communication. 

Vaccines and boosters are important, emphasized all four officials: CDC Director Dr. Rochelle Walensky, NIAID Director Dr. Anthony Fauci, Acting FDA Commissioner Dr. Janet Woodcock, and HHS Assistant Secretary Dawn O’Connell. 

On vaccination coverage: The federal government recently took key actions to increase vaccination coverage, said Dr. Walensky, including expanding eligibility of booster doses (including for adolescents) recommending third doses for immunocompromised children, and shortening the recommended time between the second dose and booster.

On testing: The Biden administration is making 500 million rapid tests available, said O’Connell—though Sen. Burr complained they would arrive after Omicron’s peak. 

On isolation: Dr. Walensky, who has faced criticism about messaging, outlined the latest CDC recommendations. (If no symptoms five days after a positive test, isolation can end, but you should wear a mask for five more days.) 

“Most people are going to get COVID,” said Dr. Woodcock, adding that vaccines are the best defense against hospitalization. Although a new study showed Omicron causes fewer hospitalizations, they hit a record Sunday.

But: “There is a 17-times-greater chance of hospitalization if you are unvaccinated. There is a 20-times-greater chance of death,” said Dr. Fauci. 

Do you have questions about the development and deployment of COVID-19 vaccines? Visit www.COVIDVaccineFacts.org.

President Biden’s Wednesday: Delivering remarks at the funeral of Gen. Raymond Odierno in Fort Myer, VA. Following questioning by the Senate HELP Committee yesterday, the White House COVID-19 Response Team and public health officials will hold a press conference. 

What’s Happening on Capitol Hill: The Senate HELP Committee closed session to consider the nomination of Robert Califf for FDA Commissioner is set for tomorrow, in an apparent rescheduling. The House Agriculture Committee will hold a hearing on the implications of electric vehicles for agriculture and rural America.